Status:
RECRUITING
Darbepoetin in Neonatal Encephalopathy Trial
Lead Sponsor:
Imperial College London
Conditions:
Neonatal Encephalopathy
Eligibility:
All Genders
1-24 years
Phase:
PHASE2
Brief Summary
Hypoxic Ischemic Encephalopathy is also known as 'birth asphyxia related brain injury' and happens when the brain does not receive enough oxygen or blood flow around the time of birth. Birth asphyxia ...
Detailed Description
Birth asphyxia related brain injury occurs in 2.6 (95% CI 2.5 to 2.8) per 1000 live births in the UK and is the most common cause of death and neurodisability in term babies. The economic burden to th...
Eligibility Criteria
Inclusion
- All the following criteria should be met
- Babies aged \< 24 hours, gestation age \>36 weeks with a birthweight \>1.8kg.
- Acute perinatal asphyxia (metabolic acidosis in cord and/or blood gas (pH\<7.0; base deficit \> 16 mmol/L) within first 1 hour of birth). If pH between 7.01 and 7.15, a base deficit between 10 and 15.9 mmol/L, additionally acute obstetric event and either need for continued resuscitation or ventilation at 10 minutes after birth and/or 10 minutes Apgar score \<5 is required.
- Evidence of mild, moderate, or severe encephalopathy on an NICHD neurological examination performed between 1 and 6 hours of birth. The worst recorded encephalopathy stage between 1 and 6 hours of birth should be used.
- Cooling therapy initiated for neonatal encephalopathy within 6 hours of age as a part of standard clinical care, with an intention of continuing for 72 hours.
Exclusion
- Major life-threatening congenital malformation.
- Concomitant participation in other research projects
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04432662
Start Date
May 28 2021
End Date
September 1 2024
Last Update
March 19 2024
Active Locations (9)
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1
Birmingham Womens Hospital
Birmingham, United Kingdom
2
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
4
Medway NHS Foundation Trust
Gillingham, United Kingdom